Many active agents used for systemic effect are administered intravenously. However, intravenous administration can be inconvenient and requires special medical equipment and trained health care providers. Moreover, many intravenous formulations are unstable and must be prepared shortly before use. Transmucosal administration, such as intranasal administration or intravaginal administration, offer alternatives to intravenous administration. However, transmucosal administration requires careful formulation. For example, compositions for intranasal administration should promote absorption of active agent via the nasal mucosae rather than through a pulmonary route.
Many different therapeutic uses of progesterone are known. For example, progesterone can be used to regulate the menstrual cycle, to support the luteal phase in in vitro fertilization methods, and in hormone replacement therapy. Compositions for intravaginal administration may be particular suited for these and similar uses, because intravaginal administration offers the benefit of delivering the drug directly and rapidly to the intended site of action, while avoiding the first-pass effect associated with, for example, oral administration.
Progesterone also can also be used to treat central nervous system injury, including traumatic central nervous system injury (such as traumatic brain injury (TBI)) and ischemic stroke. For example, recent studies have shown that treatment with progesterone can limit tissue damage and improves functional outcome after blunt TBI, stroke, spinal cord injury, diabetic neuropathies, and other types of acute neuroinjury in several species. Sayeed & Stein, in PROGRESS IN BRAIN RES. Vol. 175: 219-37 (J. Verhaagen et al., eds.) (Elsevier B. V. 2009). In clinical studies, progesterone has been administered intravenously, using formulations that are prepared shortly before use. This limits the circumstances under which progesterone can be used in emergency situations, such as when a subject has suffered TBI or ischemic stroke.
There is a need, therefore, for alternative formulations of active agents, such as progesterone, such as a dry formulation for transmucosal administration, such as nasal administration or intravaginal administration.
There also is a need for alternative formulations of other active agents, such as mometasone, including mometasone furoate, such as a dry formulation for transmucosal administration, such as nasal administration.